Label: SPORT SUNSCREEN SPF 50- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 9, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients                                                                             Purpose


    Avobenzone 3%..................................................................................Sunscreen
    Homosalate 15%.................................................................................Sunscreen
    Octisalate 5%......................................................................................Sunscreen
    Octocrylene 10%.................................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water or sweating • provides
    high protection against sunburn

  • WarningsFor external use only

    Flammable: Do not use near heat, flme, or while smoking.
    Do not use on damaged or broken skin
    When using this product • Keep out of eyes. Rinse eyes with water to remove.
    Stop use and ask a doctor if rash occurs
    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • spray liberally and spread evenly by hand 15 minutes before sun
    exposure • reapply: • after 80 minutes of swimming or sweating • immediately after
    towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face. • do not apply in
    windy conditions • use in a well-ventilated area
    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and
    early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of
    15 or higher and other sun protection measures including: • limit time
    in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts,
    pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Acrylates/Octylacrylamide, Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethylsilane, Tocopherol.

  • QUESTIONS

    Questions?
    1-800-Wegmans(934-6267) Ext 5920
    9am - 4pm EST weekdays

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPORT SUNSCREEN SPF 50 
    avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3.0   in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15.0   in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5.0   in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10.0   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearoxytrimethylsilane (UNII: 9862TW94B2)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47124-118-10340 g in 1 CAN; Type 0: Not a Combination Product05/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/18/2018
    Labeler - Wegman (059650069)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(47124-118) , label(47124-118)